Parenteral Manual

Trastuzumab

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
HERCEPTIN®, rhuMAbHER2, NSC #688097
Classification: 
Monoclonal Antibody (humanized)
Original Date: 
August 2005
Revised Date: 
Indications: 
  • Approved for use in the treatment of patients with metastatic breast cancer whose tumors substantially over express the HER2 protein
  • Investigational in children (Phase II) as adjunctive immunotherapy for metastatic osteosarcoma over expressing HER2
Reconstitution and Stability: 
  • Available as a freeze-dried powder at 440 mg per vial
  • Reconstitute with 20 mL of Bacteriostatic Water for Injection (BWFI), supplied, to give a final concentration of 21 mg/mL.  Swirl gently.  DO NOT SHAKE SOLUTION.
  • Reconstituted solution should be clear to slightly opalescent, and colorless to pale yellow
  • Solution reconstituted with BWFI is stable for 28 days in the refrigerator
  • DO NOT FREEZE reconstituted solution
  • Dilute further in 250 mL NS to administer IV.  Mix by inverting bag gently to avoid foaming.
  • Diluted solutions stable 24 hours at room temperture.  Refrigerate to avoid bacterial contamination.
Compatibility: 

- Solutions Compatibe: NS. DO NOT USE D5W.

- No other compatibility known.  Run in dedicated line.

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Push NO
IV Intermittent Infusion

YES

  • Intermittent infusion is mandatory.  Run infusion over 90 minutes until tolerance is known.  If well tolerated (absence of fever, chills, rigors, nausea, vomiting, headache, rash, asthenia, pain at tumor site), infusion time for subsequent infusions can be decreased to 60 and then 30 minutes.
IV Continuous Infusion NO
Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

  • For COG protocol AOST0121, 4 mg/kg week 1, then 2 mg/kg weekly for a further 33 weeks (total of 34 weekly doses)
  • Give prior to the start of chemotherapy

** Dosage may differ according to protocol

Potential hazards of parenteral administration: 
  • Common: fever, chills, rigors, nausea, vomiting, headache, rash, asthenia, pain at tumor site, diarrhea
  • Occasional: flu-like syndrome - paresthesias, bone pain, arthralgias
  • Rare: hypotension; anaphylaxis; ARDS; bronchospasm; dyspnea; death from allergic, pulmonary, or infusion reactions

- Treatment for unusual side effects are available through the study chair identified on the front of the protocol and/or pharmacy

Notes: 
  • Infusion requires 1:1 nursing, with vital signs (BP, HR, RR, TºC) monitoring every 15 minutes during infusion and for 60 minutes post-infusion
  • Have anaphylaxis kit available at bedside
  • Premedication with acetaminophen, antihistamine, or steroid may be required depending on tolerance
References: 

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